Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) (BICAFMS)

Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.

Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Cognitive evaluation; Behavioral: Expanded Disability Status Scale (EDSS) score

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Chu de Bordeaux
  • Caen, France, 14033
    • CHU de Caen
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand
  • Dijon, France, 21079
    • Hopital Du Bocage
  • Dunkerque, France, 59385
    • CH de Dunkerque
  • Lille, France
    • Hopital Roger Salengro
  • Lille, France, 59020
    • Centre Hospitalier Saint Vincent de Paul
  • Marseille, France, 13385
    • CHU de Marseille
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nancy, France, 54035
    • CHU de Nancy
  • Nice, France, 06002
    • CHU de Nice
  • Paris, France, 75970
    • Hopital Tenon
  • Poissy, France, 78303
    • Hôpital de Poissy Saint Germain
  • Reims, France, 51092
    • CHU de Reims
  • Strasbourg, France, 67200
    • CHU de STRASBOURG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients :

• Aged 18-64 years
• Francophone
• MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
• Having signed an informed consent (later than the day of inclusion and before any examination required by research)
• Being affiliated to health insurance

Controls:

• Aged 18-64 years
• Francophone
• Having signed an informed consent (later than the day of inclusion and before any examination required by research)
• Being affiliated to health insurance

Exclusion Criteria:

Patients:

• Other neurological diseases with impact on cognitive functions.
• Severe psychiatric disease or severe depression.
• Current Dependence on alcohol or drugs.
• Modification or stop of psychotropic treatment in less than a month.
• Modification of MS treatment in less than a month.
• Visual, visual-motor and / or motor impairments excluding the ability to perform cognitive tests.
• Pregnant

Controls:

• Neurologic disease and known chronic systemic with impact on cognitive functions.
• Severe psychiatric disease or severe depression.
• Current Dependence on alcohol or drugs.
• Psychotropic treatment
• Cognitive complaint
• Prior cognitive testing with the same tests less than one year.
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control; healthy subject	Behavioral: Cognitive evaluation; Questionnaires for assessment of confounding factors; Cognitive evaluation; Walking tests and 9 Hole Peg Test
EXPERIMENTAL: Patient; MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms	Behavioral: Cognitive evaluation; Questionnaires for assessment of confounding factors; Cognitive evaluation; Walking tests and 9 Hole Peg Test; Behavioral: Expanded Disability Status Scale (EDSS) score; - EDSS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects	average z scores of CEVMT and CSCT	At the inclusion (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education	BCCAMS and MACFIMS	At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory	California verbal learning test-II and brief-visual memory test-revised	At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)	congnitive test	At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Prediction between cognitive impairment and occupational status/leisure activities	questionnaire	At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue	scale	At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis	congnitive test	At 1 and 6 months after the inclusion (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2015
• Primary Completion (ACTUAL): February 18, 2018
• Study Completion (ACTUAL): February 18, 2018

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (ESTIMATE): March 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: cognition; brief computerized cognitive assessment; impairment prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CHUBX 2013/23